Peyronies treatment device

ABSTRACT

A Peyronie&#39;s treatment device is described that is configured to treat an erect penis having curvature characterized by a first penis side with an unaffected length and a second penis side with an affected length that is shorter than the unaffected length. The device includes a band connected between a proximal support that is attachable to a base of a penis and a distal support that is attachable adjacent a corona of the penis. The band has an elastic material and a second material that is attached to the elastic material. The second material is provided to stop elongation of the elastic material at a length approximately equal to the affected length of the erect penis.

BACKGROUND

Peyronie's disease is manifested by an abnormal bend that occurs in theerect penis of the sufferer and can be associated with painful erectionand/or painful intercourse.

Peyronie's disease is related to the development of scar tissue, orplaques, that form on tissues (e.g., tunica albuginea) inside the penis.One non-surgical approach for the treatment of Peyronie's diseaseincludes injecting drugs into the plaques that lessen the compressionapplied by the plaques to the erect penis. The research and efficacy ofthis approach is limited.

Surgical treatments for Peyronie's disease include excising portions ofthe tunica albuginea from the penis opposite the plaque and closing thefenestrations with sutures. Access to the tunica albuginea is achievedby first degloving the penile skin away from the penis to expose theBuck's fascia and tunica albuginea along the length of the penis.Degloving the penile skin is painful and the recovery time for thepatient can be several weeks. Although the long term results of thissurgical approach are good, both short term (within 8 weeks) and longterm failures can present with residual penile deformity.

Another surgical treatment includes corporal plication in whichplication sutures are placed on the contralateral side of the plaquewithout excising the tunica albuginea or removing the plaque. Corporalplication is most commonly employed subsequent to a previous Peyronie'streatment surgery to correct small angles of residual penile deformity.

Patients and clinicians desire more effective and less invasive surgicaltreatments for Peyronie's disease.

SUMMARY

One aspect provides a Peyronie's treatment device configured to treat anerect penis having curvature characterized by a first penis side with anunaffected length and a second penis side with an affected length thatis shorter than the unaffected length. The device includes a bandconnected between a proximal support that is attachable to a base of apenis and a distal support that is attachable adjacent a corona of thepenis. The band has an elastic material and a second material that isattached to the elastic material. The second material is provided tostop elongation of the elastic material at a length approximately equalto the affected length of the erect penis.

One aspect provides a method of treating Peyronie's disease manifestedin an erect penis having a first penis side with an unaffected lengthand a second penis side with an affected length that is shorter than theunaffected length. The method includes attaching an elastic devicesubcutaneously to the first penis side; and providing the elastic devicewith a stretch stop that limits elongation of the first penis side to anerection distance that is approximately equal to the affected length ofthe erect penis.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1A is a top view and FIG. 1B is a cross-sectional view of oneembodiment of a Peyronie's treatment device having an elastic materialin a relaxed state.

FIG. 2A is a top view and FIG. 2B is a cross-sectional view of oneembodiment of the Peyronie's treatment device illustrated in FIGS. 1Aand 1B with the elastic material stopped in a stretched state by asecond material that is attached to the elastic material.

FIG. 3A is a side schematic view of an erect penis afflicted byPeyronie's disease.

FIG. 3B is a side schematic view of the penis illustrated in FIG. 3A ina flaccid state and including the treatment device illustrated in FIGS.1A and 1B attached to the tunica albuginea of the penis.

FIG. 3C is a side schematic of the penis illustrated in FIG. 3B in anerect state having reduced curvature as compared to the untreated penisillustrated in FIG. 3A.

FIG. 4A is a top view of one embodiment of a Peyronie's treatment devicein a relaxed, un-stretched state.

FIG. 4B is a top view of a band of the device illustrated in FIG. 4Ashowing a stop strand.

FIG. 4C is a top view of the Peyronie's treatment device illustrated inFIG. 4A in an elongated state.

FIG. 4D is a top view of the band of the device illustrated in FIGS. 4Aand 4C showing the stop strand limiting elongation of the device.

FIG. 5 is a perspective view of one embodiment of a Peyronie's treatmentdevice.

FIG. 6 is a block diagram of one embodiment of a method of treatingPeyronie's disease.

FIG. 7 is a block diagram of one embodiment of a method of treatingPeyronie's disease.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Soft tissue includes dermal tissue, sub-dermal tissue, ligaments,tendons, or membranes but does not include bone.

The term “proximal” as employed in this application means that part thatis situated next to or near the point of attachment or origin or acentral point: as located toward a center of the human body. The term“distal” as employed in this application means that part that issituated away from the point of attachment or origin or the centralpoint: as located away from the center of the human body. A distal endis the furthest endmost location of a distal portion of a thing beingdescribed, whereas a proximal end is the nearest endmost location of aproximal portion of the thing being described. For example, the glanspenis is located distal and of the crus of the penis is located proximalrelative to the male body such that a distal end of a corpora cavernosumof the patient extends about midway into the glans penis.

Embodiments provide an internal traction device that treats the effectsof Peyronie's disease by reducing the curvature of an erect penis. Inone embodiment, the device is attached subcutaneously to an exteriorsurface of the tunica albuginea on a contralateral side of the penisopposite the side on which the Peyronie's plaques have formed andfunctions to counteract the asymmetrical contraction of the penis causedby the Peyronie's plaques. The device is fabricated from a stretchymaterial that accommodates movement of the penis between a flaccid stateand an erect state. The device is configured to stretch and elongate upto a built-in stop-limit length that is selected to match the length ofthe penis on the side on which the Peyronie's plaques have formed. Inthis manner, all sides of the penis elongate to an approximately equallength.

In one embodiment, the device is attached to the tunica albuginea of thepenis without incising the tunica or removing the Peyronie's plaques,and thus use of the device limits patient discomfort and reduces thehealing time for the Peyronie's-afflicted patient compared to otherprocedures.

FIG. 1A is a top view and FIG. 1B is a cross-sectional view of oneembodiment of a Peyronie's treatment device 20. The Peyronie's treatmentdevice 20 (device 20) is provided as a band 20 that includes an elasticmaterial 22 extending between a proximal support 24 that is attachableto a base of a penis and a distal support 26 that is attachable adjacenta corona of the penis, and includes a second material 28 attached to theelastic material 22. In one embodiment, the device 20 providesattachment locations 30 that allow the device 20 to be attachedsubcutaneously within the penis.

Patients who suffer from Peyronie's disease develop a curvature in theerect penis characterized by one side of the penis having an unaffectedlength and, generally, an opposite side of the penis having an affectedlength that is shorter than the unaffected length of the penis. The band20 provides a length that is selected to stretch between a first initiallength L1 extending between a base of the penis and a corona of thepenis when the penis is flaccid to a final length L2 (FIG. 2) that isapproximately equal to be affected length of the penis. The elasticmaterial 22 is thus configured to move with the penis between itsflaccid state and its erect state, and when the penis is erect, thedevice 20 is configured to straighten the penis to an approximatelysymmetric shape/length.

In one embodiment, the second material 28 provides a stop for theelastic material 22 that allows the elastic material 22 to stretch fromthe initial length L1 to the final length L2, where the final length L2is selected prior to surgery to be approximately equal to the affectedlength of the Peyronie's-affected erect penis. In one embodiment, thesecond material 28 provides means for limiting elongation of thestretchable band 20 to a distance that is greater than the affectedlength of the Peyronie's-affected erect penis.

In one embodiment, the band 20 is elastically deformable between theinitial length L1 and the final length L2 and the second material 28configures the band 20 to be inelastically deformable past the finallength L2. That is to say, the band 20 is stretchable up to the finallength L2, and if a sufficiently large force is applied to the band 20to stretch it beyond the length L2, the band will fracture or otherwisebreak. Thus, the elastic material 22 is stretchable from the initiallength L1 that is less than the affected length to a length that isgreater than the affected length, and the second material 28 preventselongation of the elastic material 22 past the affected length.

In one embodiment, the elastic material 22 is provided as a knittedfabric and the second material 28 is provided as a separate fabric 28that is attached to the knitted fabric 22, where the separate fabric 28has some limited degree of stretch that allows the elastic material 22to stretch up to the desired the final length L2 before the separatefabric 28 stops the elongation of the elastic material 22 at the finallength L2. The separate fabric 28 thus allows the elastic material 22 tostretch up to but not beyond the final length L2. With this in mind, oneembodiment of the band 20 includes stretching the elastic material 22 tothe final length L2 and attaching the separate fabric 28 to the elasticmaterial 22. When the elastic material 22 is relaxed the separate fabric28 moves with the elastic material 22. When the elastic material 22 isstretched, the separate fabric 28 moves to allow the elastic material 22to stretch up to but not beyond the final length L2.

In one embodiment, the elastic fabric 22 is provided as a knitted fabricand the second material 28 is provided as an inelastic woven fabric thatis attached to the knitted fabric. In one embodiment, the inelasticwoven fabric 28 has a fixed length generally equal to L2 and is attachedto the elastic fabric 22 in a manner (similar to that described above)that allows the elastic material 22 to stretch up to but not beyond thefinal length L2.

In one embodiment, the elastic material 22 is provided as a knittedfabric and the second material 28 is provided as inelastic strand 28embedded in the knitted fabric. As an example, the elastic material 22is stretched to the final length L2 and the inelastic strand 28 isattached to the elastic material 22 to limit its elongation. In oneembodiment, the inelastic strand 28 is fixed to the elastic fabric 22 ina manner that allows the elastic material 22 to stretch up to but notbeyond the final length L2.

The elastic material 22 is stretchable between the initial length L1 anda length that is longer than the final length L2, and a second material28 is provided to stop the elongation of the elastic material 22 at thefinal length L2. The knitted fabrics of the elastic material 22 aresuitably fabricated from polymer fiber such as polypropylene,polyethylene, or polyolefin or such fibers coated with slip agents orelastic additives. The second material 28 is suitably fabricated from,as an example, nylon thread(s) woven or otherwise processed to provide astop to the elongation of the elastic material 22 at the final lengthL2. The second material 28 is suitably fabricated from an inelasticsuture filament.

Knitted fabrics are generally fabricated from a filament that is knit ona path to form a chain of loops, where each loop in the chain of loopsis suspended by a neighboring loop. The loops are secured as they areknit by passing a newly formed loop through a previously formed loop.The chain of loops that run in a lateral direction are referred to as awale, and the path that the knitting filament follows is referred to asa course (see FIG. 4B as an example of a knitted fabric).

A woven material is different from a knitted material in that wovenmaterial is formed by threads that run parallel in a lengthwisedirection (warp threads) and cross with a separate set of parallelthreads placed in a crosswise direction (weft threads). Woven materialscan thus be fabricated that have little or no stretch as the warp andweft threads connect together to limit their mutual movement. Incontrast, the meandering course that forms the loops of a knittedmaterial provide the knit with greater elasticity (e.g., stretchiness)over the woven material since the loops move within each other.

With the above mind, the device 20 or the band 20 is provided inmultiple formats (for example, each with a different final length L2)that allow the surgeon to select the desired final length L2 as based onthe affected length of the erect penis of the patient suffering fromPeyronie's disease.

FIG. 2A is a top view and FIG. 2B is a cross-sectional view of thePeyronie's treatment device 20 illustrated in FIG. 1 with the elasticmaterial 22 stopped at a desired elongated length by the second material28.

FIGS. 3A, 3B, and 3C are schematic views of a penis P.

FIG. 3A is a side schematic view of a Peyronie's afflicted erect penis.The erect penis P has a pair of corpora cavernosa CC that extend from aproximal location internal to the body up to a mid-location of the glanspenis. The illustrated erect penis P includes plaques that have formedon an affected side 40 of the penis P that cause the erect penis P tohave an affected length La. The penis P has an unaffected side 42 thatis generally opposite the affected side 40 of the penis. The unaffectedside 42 of the penis P has an unaffected length of Lu. The affected side40 of the erect penis is generally shorter than the unaffected side 42of the erect penis such that the erect penis P presents with anundesirable curvature.

FIG. 3B is a side schematic view of the penis P including the band 20subcutaneously attached to the tunica albuginea TA of the penis P. Thetunica albuginea TA of the penis P encapsulates the corpora cavernosaCC. The proximal support 24 of the band 20 is attached to a base B ofthe penis P and the distal support 26 is attached adjacent to a corona Cof the penis P, for example by suturing through the attachment locations30.

In one embodiment, the band 20 is attached subcutaneously to the tunicaalbuginea TA of a flaccid penis P. For example, the band 20 is providedin a variety of lengths that allows the surgeon to selective a band 20having the appropriate initial length L1 and an appropriate final lengthL2 based on pre-treatment measurements, and knowing these lengths, thesurgeon selects the appropriately sized band 20 for attachment to theflaccid penis P.

Alternatively, in one embodiment the band 20 is attached subcutaneouslyto the tunica albuginea TA of an erect penis P. For example, the surgeonartificially induces an erection in the penis P to observe the angle andextent of the curvature in the Peyronie's affected penis, and afterrecording this data, selects a band 20 having a final elongated lengthL2 that is approximately equal to the affected length La of the erectpenis. The selected band 20 is attached to the erect penis to provide asuitable amount of correction to the curvature of the Peyronie'saffected penis P.

FIG. 3C is a side schematic view of the erect penis P including plaquespresent on the affected side 40 of the Peyronie's afflicted penis andthe band 20 attached subcutaneously to the tunica albuginea to provide acorrecting force that resists curvature of the penis P. The erect penisP is thus provided with symmetric sides 40, 42 in which the band 20configures the unaffected side 42 of the penis P to have a length thatis approximately equal to the affected length La of the penis P. Asillustrated by FIG. 3C, the final length L2 of the band 20 has a lengththat is substantially equal to the affected length La of the penis (FIG.3A).

FIG. 4A is a top view of one embodiment of a Peyronie's treatment device50 (device 50). The device 50 is provided with multiple bands 51 havingelastic material 52 extending between a proximal support 54 that isattachable to a base of a penis and a distal support 56 that isattachable adjacent a corona of the penis, and a second material 58attached to the elastic material 52 that is provided to stop elongationof the elastic material 52 at a length approximately equal to theaffected length of a Peyronie's affected erect penis.

In one embodiment, the proximal support 54 is provided as a segment thatis attachable to less than an entire circumference of the base of thepenis P. In one embodiment, the distal support 56 is provided as asegment that is attachable to less than an entire circumference of thepenis adjacent the corona.

FIG. 4A illustrates the device 50 having an initial length L1 in arelaxed state and FIG. 4C illustrates the device 50 stretched orelongated to a final length L2 that is selected to be substantiallyequal to the affected length of an erect Peyronie's affected penis.

FIG. 4B is a top view of one of the bands 51 including a filament 53knit on a path to form a chain of loops 55, where each loop 57 in thechain of loops 55 is suspended by a neighboring loop 59. In this manner,the loops 55 are secured as they are knit by passing a newly formed loop(e.g., loop 57) through a previously formed loop (e.g., loop 59). Thechain of loops that run left-to-right in FIG. 4B are referred to as awale W. The path that the filament 53 follows is referred to as a courseC. In one embodiment, the second material 58 is a strand 58 that isinterlaced or woven into the chain of loops 55, where the strand 58 isprovided to limit the elongation of the knitted loops in the band 51. Inone embodiment, the bands 51 and the strand 58 are each attached onopposing ends between the proximal support 54 and the distal support 56,and when the band 51 is stretched, the strand 58 stops the elongation ofthe band 51 at the desired length L2.

FIG. 4D illustrates the strand 58 stopping the elongation of the device50 at the final length L2 that is substantially equal to the affectedlength of an erect Peyronie's affected penis.

FIG. 5 is a top view of one embodiment of a Peyronie's treatment device60 (device 60). The device 60 is provided with multiple bands 61 havingelastic material 62 extending between a proximal support 64 that isattachable to a base of a penis and a distal support 66 that isattachable adjacent a corona of the penis, and a second material 68attached to the elastic material 62 that is provided to stop elongationof the elastic material 62 at a length approximately equal to theaffected length of a Peyronie's affected erect penis.

In one embodiment, the proximal support 64 is provided as a continuousring that is attachable around an entire circumference of the base ofthe penis P and the distal support 66 is provided as a continuous ringthat is attachable around an entire circumference of the penis adjacentthe corona.

FIG. 6 is a block diagram 70 of one embodiment of a method of treatingPeyronie's disease. The method of treatment includes at 72 providing anelastic device that is attachable subcutaneously to the penis. Themethod of treatment includes at 74 providing the elastic device with astretch stop that limits the elongation of the device to a distance thatis approximately equal to the affected length of a Peyronie's afflictederect penis (see FIG. 3A).

FIG. 7 is a block diagram 80 of one embodiment of a method of treatingPeyronie's disease. The method of treatment includes at 82 evaluatingcurvature and a shortened length of an erect penis of a patientafflicted by Peyronie's disease. The method of treatment includes at 84selecting an elastic device having a stretch stop that limits theelongation of the elastic device to approximately the shortened lengthof the erect penis. The method of treatment includes at 86 attaching theelastic device to a side of the penis, subcutaneously to the tunicaalbuginea, opposite the side of the penis having the curvature. Themethod of treatment includes at 88 configuring the elastic device tostretch with the erection of the penis and configuring the stretch stopto apply tension to the side of the penis having the curvature, thusreducing the curvature of the erect penis.

EXAMPLE

The following example illustrates, with reference to FIG. 3A, thesurgical placement of one of the Peyronie's treatment devices describedabove without degloving the penile skin.

The patient is anesthetized and surgically draped to define a sterileoperating field in an appropriate manner.

The surgeon forms a circumcoronal incision adjacent to the glans penisand a penoscrotal incision adjacent to the base of the penis P. Thedartos fascia is reflected to expose the Buck's fascia, and the Buck'sfascia is incised down to the tunica albuginea.

The surgeon introduces a flat-bladed tool subcutaneous to the penis overthe tunica albuginea and forms a pathway extending from the penoscrotalincision to the circumcoronal incision along the unaffected side 42 ofthe penis P.

In one embodiment, an artificial erection is imparted to the penis Pwith an intracavernous injection of saline solution and the surgeonproceeds to attach one of the above-described Peyronie's treatmentdevices to an exterior surface of the tunica albuginea on acontralateral side of the penis opposite the side on which thePeyronie's plaques have formed.

The proximal support 24 is attached to the base of the penis P, forexample with one or more sutures. The flat-bladed tool, or a forceps, isemployed to deliver the distal support 26 to a location adjacent acorona of the penis. The surgeon corrects the curvature in the penis P(e.g., manually) and attaches the distal support 26 to the penis at alocation that conforms the unaffected side 42 of the penis P to have alength that approximates a length of the affected side 40 of the penisP. In this manner, the implanted Peyronie's treatment device correctsthe curvature in the penis.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

1. A Peyronie's treatment device configured to treat an erect penishaving curvature characterized by a first penis side with an unaffectedlength and a second penis side with an affected length that is shorterthan the unaffected length, the device comprising: a band connectedbetween a proximal support that is adapted to be attached to a base of apenis and a distal support that is adapted to be attached adjacent acorona of the penis, the band comprising an elastic material and asecond material that is attached to the elastic material, the secondmaterial provided to stop elongation of the elastic material at a lengthapproximately equal to the affected length of the erect penis.
 2. Thedevice of claim 1, wherein the band is stretchable between an initiallength that is less than the affected length to a final length that issubstantially equal to the affected length.
 3. The device of claim 2,wherein the band is elastically deformable between the initial lengthand the final length and inelastically deformable past the final length.4. The device of claim 1, wherein the elastic material is stretchablefrom an initial length that is less than the affected length to a finallength that is greater than the affected length and the second materialprevents elongation of the elastic material past the affected length. 5.The device of claim 1 comprising multiple bands connected between theproximal support and the distal support.
 6. The device of claim 1,wherein the proximal support comprises a continuous ring that is adaptedto be attached around an entire circumference of the base of a penis. 7.The device of claim 1, wherein the proximal support comprises a proximalsupport segment that is adapted to be attached to less than an entirecircumference of the base of a penis.
 8. The device of claim 1, whereinthe distal support comprises a continuous ring that is adapted to beattached around an entire circumference of the penis adjacent to thecorona of the penis.
 9. The device of claim 1, wherein the distalsupport comprises a distal support segment that is adapted to beattached to less than an entire circumference of the penis adjacent tothe corona of the penis.
 10. The device of claim 1, wherein the elasticmaterial comprises a knit fabric and the second material comprises aninelastic strand embedded in the knit fabric.
 11. The device of claim 1,wherein the elastic material comprises a knit fabric and the secondmaterial comprises an inelastic fabric attached to the knit fabric. 12.The device of claim 1, wherein the elastic material comprises a knitfabric and the second material comprises an inelastic woven fabricattached to the knit fabric.
 13. The device of claim 1, wherein the bandis attached to the first penis side having the unaffected length and thesecond material stops elongation of the first penis side of the erectpenis at an erection distance of approximately the affected length ofthe erect penis to reduce the curvature of the erect penis.
 14. APeyronie's treatment device configured to treat an erect penis havingcurvature characterized by a first penis side with an unaffected lengthand a second penis side with an affected length that is shorter than theunaffected length, the device comprising: a stretchable band connectedbetween a proximal support that is adapted to be attached to a base of apenis and a distal support that is adapted to be attached adjacent acorona of the penis; and means for limiting elongation of thestretchable band to a distance that is no greater than the affectedlength.
 15. The device of claim 15, comprising means for reducing thecurvature of the erect penis.
 16. The device of claim 15, comprisingmeans for allowing the first penis side of the erect penis to elongateup to a distance that does not exceed the affected length of the erectpenis.